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A Safety and Efficacy Study of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Participants With Multiple Sclerosis — MOTION - JAPAN  

Multiple Sclerosis Clinical Trial

Official title:
A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Subjects With Multiple Sclerosis Followed by an Open-Label Safety Extension

Clinical Trial Summary

This is a multicenter study conducted in 3 parts. Part A is a double-blind placebo-controlled parallel-group period, and Part B and C are open-label extension periods. The primary objective of the double-blind study (Part A) is to assess the effect of Prolonged-Release Fampridine treatment on walking speed as measured by the T25FW (timed 25 foot walk) in Japanese participants with Multiple Sclerosis. The secondary objective of the double-blind portion of the study is to evaluate the safety and tolerability of prolonged-release Fampridine in this study population. The primary objective of the open-label extension study (Part B) is to evaluate the long-term safety profile of prolonged-release Fampridine. The primary objective of the additional open-label extension (Part C) is to provide participants who complete the study with continued access to prolonged-release fampridine until marketed drug can be used at the applicable site or until sponsor decision to discontinue the study.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Multiple Sclerosis
  • Multiple Sclerosis, Chronic Progressive
  • Multiple Sclerosis, Primary Progressive
  • Multiple Sclerosis, Relapsing-Remitting
  • Multiple Sclerosis, Remittent Progressive
  • Relapsing-Remitting Multiple Sclerosis
  • Sclerosis
  • Secondary Progressive Multiple Sclerosis
Clinical Trial Details
NCT number NCT01917019
Study type Interventional
Source Biogen
Contact
Status Completed
Phase Phase 3
Start date August 2013
Completion date March 2017
View Details
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